Methods and apparatus for anastomosis including an expandable anchor

ABSTRACT

The present disclosure is directed to devices for approximating body vessels and method for performing the same. In accordance with one aspect of the present disclosure, the device includes an inner member, an outer member having a lumen dimensioned to receive the inner member, an expandable anchor for engaging the a first body vessel, and a joining member for engagement between the first body vessel and the second body vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.10/503,743, filed on Aug. 4, 2004, now U.S. Pat. No. 7,648,515, which isa National Phase Application filed under 35 U.S.C. §371 of InternationalApplication Serial No. PCT/US2003/011913, filed on Apr. 16, 2003, whichclaims benefit of and priority to U.S. Provisional Patent ApplicationSer. No. 60/373,223 filed on Apr. 16, 2002, and the disclosures of eachof the above-identified applications are hereby incorporated byreference in their entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to devices and methods used for joiningtissue portions and, more particularly, to anastomotic devices andmethods for positioning and joining tissue cavities to one another. Thepresent disclosure also relates to devices with anchors and methods ofusing the same.

2. Background of Related Art

Anastomosis is the bringing together and/or joining of two hollow ortubular structures. For example, the removal of cancerous growth ortreatment of cancerous tissue can result in a need to connect twoportions of organs or two body conduits in fluid communication with oneanother. Most body conduits are generally cylindrical in configurationand have a generally circular cross-section. When it is desired tosuture such a conduit to another body conduit, typically sutures areplaced around the circumference of the conduits in order to maintaintheir patency and in order to maintain its lumen or channel. It can beappreciated that the sutures made on top of the conduits in at leastcertain anastomotic procedures are made relatively easier than thesutures made underneath the conduits.

The complexity of anastomosis attachment is made manifestly apparent ina surgical procedure referred to generally as a radical prostatectomy(i.e., a well established surgical procedure for patients with localizedprostatic carcinoma). Radical prostatectomy procedures, for example,require the removal of the cancerous tissue while attempting to preservethe sexual capability and continence of a patient.

The radical prostatectomy surgical procedure is generally concluded withthe joining of the bladder, in particular the bladder neck, to theurethra, in particular the urethral stump, preparing and positioning thebladder and urethra for a mucosa-to-mucosa joining, and suturing thebladder neck and the urethral stump in position. This may beaccomplished using minimally invasive surgery. The current radicalprostatectomy procedure is hampered by poor accessibility, the friablenature of the urethra, and the close proximity of important sexual andcontinence related organs to the surgical site. In addition, the radicalprostatectomy procedure is further complicated by the tendency of theurethral stump to retract into adjacent tissue. As a result,considerable time and effort must be expended to re-expose the urethralstump and begin the anastomosis procedure. Further complicating thisprocedure is the fact that the urethral stump is hidden beneath thepubic bone thus requiring that the surgeon work at a difficult angle andin positions that are uncomfortable and limiting.

Various devices have been proposed for facilitating a radicalprostatectomy procedure. In U.S. Pat. No. 5,591,179 issued to Edelsteinthere is disclosed a suturing device including a shaft with portionsdefining an interior channel extending between the proximal and distalends of the shaft. This channel includes a generally axial lumen whichextends to the proximal end and a generally transverse lumen whichextends from the axial lumen distally outwardly to an exit hole at theouter surface of the shaft. A needle and suture can be back loaded intothe transverse lumen of the channel while a generally non-compressiblemember can be movably mounted in the axial lumen of the channel. At theproximal end of the shaft a handle is provided with means operative topush the member distally through the lumen to deploy or expel theneedle.

In U.S. Pat. No. 4,911,164 issued to Roth there is disclosed a sutureguide with a curved distal portion. This distal portion has a pluralityof exterior axial grooves which can be used to align and guide a curvedneedle and attached suture. In order to drive the urethral stump to anaccessible position, the device is provided with a plurality ofoutwardly extendable members which engage the lumen of the urethra.These members make it possible to push the urethral stump intoapproximation with the bladder neck.

In U.S. Pat. No. 5,047,039 issued to Avant et al. there is disclosed asurgical device for the ligation of a dorsal vein and subsequentanastomosis. This device contains a pair of enclosed needles each havingan attached suture which needles may be driven from the shaft of thedevice into adjacent tissue.

In addition, surgical anastomosis instruments having a “one shot”approach for quickly securing two vessel portions have been developedand include end-to-side anastomosis instruments which are typically usedin the aortic and coronary regions of the body. End-to-end andside-to-side anastomosis instruments for joining vessel portionstogether are also well known. These instruments typically use metalfasteners or staples having a “U” or a “C” shape to join the tissueportions to one another. There are applications, however, such as withthe urethra, where the use of metal fasteners or staples are known toincrease the likelihood of future complications.

Accordingly, a continuing need exists for anastomosis devices forperforming procedures such as a radical prostatectomy that can positionone vessel portion, e.g., the bladder and/or bladder neck, adjacent asecond vessel portion, e.g., the urethra and/or urethral stump, foranastomosis with or without the use of minimally invasive surgery or theuse of sutures, clips and/or staples. In addition, a continuing needexists for anastomosis devices which reduce the amount of handling ofthe vessel portions which can ultimately lead to poor recovery of avessel function.

SUMMARY

The present disclosure is directed to devices for approximating bodyvessels. According to an aspect of the present disclosure, a device forapproximating body vessels includes an inner member having a firstexpandable anchor operatively coupled near a distal end thereof, anouter member having a lumen and disposed about the inner member, theouter member having a second expandable anchor, and a radiallyexpandable sleeve disposed about at least a portion of the outer memberfor engaging the juncture of portions of the body vessels. It isdesirable that the inner member has a lumen.

It is envisioned that the first expandable anchor and the secondexpandable anchor are configured and adapted to radially expand thesleeve. The first expandable anchor has an initial condition in whichthe radius of the expandable anchor is substantially equal to the radiusof the inner member and an expanded condition in which the radius of theexpandable anchor is larger than the radius of the inner member. Thesecond expandable anchor has an initial condition in which the radius ofthe second expandable anchor is substantially equal to the radius of theouter member and an expanded condition in which the radius of the secondexpandable anchor is larger than the radius of the outer member.

It is envisioned that the device further may include a third expandableanchor on the outer member for engaging a body vessel. The first, secondand third expandable anchors are desirably separately expandable.

The sleeve is preferably made from a porous material. More preferably,the sleeve is made of substantially non-elastic filaments. The sleevemay be made of a braid or other fabric of filaments. It is furtherenvisioned that the sleeve is made from a bio-absorbable material. Thebio-absorbable material is at least one of polyglycolic acid andpolylactic acid. The sleeve is desirably impregnated with a medicaladhesive.

It is envisioned that at least one of the first expandable anchor, andthe second expandable anchor is expandable via fluid inflation. It isfurther envisioned that at least one of the first expandable anchor andthe second expandable anchor comprises a balloon.

The inner member includes an inflation/deflation lumen extendingtherethrough, and wherein the inflation/deflation lumen of the innermember is in fluid communication with the first expandable anchor. Theouter member includes an inflation/deflation lumen for the secondexpandable anchor in fluid communication with the second expandableanchor.

The first expandable anchor may be made of an inextensible material, oran expandable and/or stretchable material having suitable structuralintegrity and strength for the movement, positioning and/orrepositioning of at least a portion of a body organ.

According to another aspect of the present disclosure, the device forperforming a surgical anastomosis includes an inner catheter having adistal end, a proximal end and defining an axial lumen therethrough, theinner catheter including a first expandable anchor operatively couplednear the distal end thereof, an outer catheter having a distal end, aproximal end and a lumen for receiving the inner catheter extendingtherethrough, and a radially expandable sleeve disposed about at least aportion of the inner catheter and at least a portion of the outercatheter for engaging the juncture between portions of two body vessels.The outer catheter includes a distal expandable anchor operativelycoupled near the distal end of the outer catheter, and a proximalexpandable anchor operatively coupled near the distal end of the outercatheter at a location proximal of the distal expandable anchor.

It is envisioned that at least one of the expandable anchor, the distalexpandable anchor and the proximal expandable anchor is expandable byfluid inflation. It is further envisioned that at least one of theexpandable anchor, the distal expandable anchor and the proximalexpandable anchor comprises a balloon.

The inner catheter includes an inflation/deflation lumen extendingtherethrough, wherein the inflation/deflation lumen of the innercatheter is in fluid communication with the first expandable anchor. Theouter catheter includes an inflation/deflation lumen for each of thedistal expandable anchor and the proximal expandable anchor extendingtherethrough, wherein each inflation/deflation lumen is in fluidcommunication with a respective distal expandable anchor and proximalexpandable anchor.

The sleeve may be made from a braid of individual substantiallynon-elastic filaments. Preferably, the sleeve is made from a porousmaterial. It is contemplated that the sleeve is impregnated with amedical adhesive.

The sleeve has a first condition having a first radius which issubstantially equal to a radius of the outer catheter and a secondcondition having a second radius which is larger than the radius of theouter catheter.

According to another aspect of the present disclosure, a method ofapproximating a first body vessel and a second body vessel is provided.The method includes the step of providing a device for performing thesurgical anastomosis. The device includes an inner member having a firstexpandable anchor operatively coupled near a distal end thereof, anouter member having a lumen for receiving the inner member, the outermember having a second expandable anchor, and a radially expandablesleeve disposed about at least a portion of the outer member forengaging the juncture of the body vessels.

The method further includes the steps of passing the device through thefirst body vessel and into the second body vessel, engaging the firstexpandable anchor with the second body vessel such that the distal endof the sleeve engages the second body vessel, engaging the secondexpandable anchor of the outer member with the first body vessel, movingthe inner member so that the second body vessel contacts the first bodyvessel, and engaging the second expandable anchor with the first bodyvessel such that a proximal end of the sleeve engages the first bodyvessel.

It is envisioned that the steps of engaging includes expanding at leastone of the first and second expandable anchors.

It is envisioned that the method further includes the step of retractingthe first expandable anchor and the second expandable anchor in order towithdraw the device from the first and second body vessels. It isfurther envisioned that the method further includes the step of applyinga medical adhesive between the sleeve and both of the first body vesseland the second body vessel.

The sleeve includes a porous material. It is envisioned that the methodfurther includes impregnating the sleeve with a medical adhesive. Thesleeve is made from a braid of individual non-elastic filaments.

It is envisioned that at least one of the first expandable anchor andthe second expandable anchor are expandable via inflation. The methodfurther includes the step of inflating the at least one of the firstexpandable anchor and the second expandable anchor.

According to a further aspect of the disclosure, a device for performinga surgical anastomosis is disclosed. The device includes an inner memberhaving a first expandable anchor operatively coupled near a distal endthereof, wherein the first expandable anchor includes a proximal endportion defining an annular concave region when in an expandedcondition, the annular concave region of the expandable anchor beingconfigured and adapted to evert a portion of body tissue when theexpandable anchor is expanded, and an outer member having a lumen forreceiving the inner member.

It is envisioned that the device further includes a second expandableanchor operatively coupled to the outer member. The first expandableanchor has a retracted condition in which the radius of the firstexpandable anchor is substantially equal to the radius of the innermember and an expanded condition in which the radius of the firstexpandable anchor is larger than the radius of the inner member. Thesecond expandable anchor has a retracted condition in which the radiusof the second expandable anchor is substantially equal to the radius ofthe outer member and an expanded condition in which the radius of thesecond expandable anchor is larger than the radius of the outer member.It is envisioned that the device further includes a proximal expandableanchor with a retracted condition in which the radius of the proximalexpandable anchor is substantially equal to the radius of the outermember and an expanded condition in which the radius of the proximalexpandable anchor is larger than the radius of the outer member.

The first expandable anchor is expandable via fluid inflation. It isenvisioned that the first expandable anchor is made of an expandableand/or stretchable material having suitable structural integrity andstrength for the movement, positioning and/or repositioning of at leasta portion of a body organ. The first expandable anchor includes aballoon.

It is envisioned that the outer member is slidably disposed about theinner member, the outer member having a distal expandable anchoroperatively coupled near a distal end of the outer member, wherein thedistal expandable anchor includes a distal portion defining an annularconcave region when in an expanded condition, the annular concave regionof the distal expandable anchor being configured and adapted to evert aportion of body tissue when the distal expandable anchor is expanded.

According to a further aspect of the present disclosure, a method ofapproximating a first body vessel and a second body vessel is provided.The method includes the steps of providing a member having a distal endand an expandable anchor disposed at the distal end, the expandableanchor comprising a membrane defining a chamber, introducing the memberthrough the first body vessel and into the second body vessel, expandingthe expandable anchor by introducing a fluid into the chamber, so thatthe expandable anchor engages the second body vessel, and moving thesecond body vessel toward the first body vessel.

The method further includes deploying fastening means connecting thefirst body vessel and the second body vessel. The method still furtherincludes collapsing the expandable anchor and removing the member andthe expandable anchor.

It is envisioned that the member includes an inner member and furthercomprising an outer member having a lumen for receiving the innermember, the outer member having an expandable anchor. The method furtherincludes expanding the expandable anchor after the step of moving thesecond body vessel, so that the expandable anchor engages the first bodyvessel.

According to yet another aspect of the present disclosure, a device forapproximating body vessels is provided. The device includes a memberhaving a distal end and an expandable anchor disposed at the distal end,the expandable anchor comprising a membrane defining a chamber, andfastening means carried by the expandable anchor for engaging the bodyvessels.

The fastening means includes a sleeve disposed around the expandableanchor so that upon expansion of the expandable anchor, the sleeveengages the body vessel. The fastening means includes a medicaladhesive. The member includes an inner member and further includes anouter member having a lumen for receiving the inner member andexpandable anchor thereon. Preferably, the outer member is movable withrespect to the inner member for positioning the fastening means. It isenvisioned that the device further includes an expandable cuff on theouter member.

These objects together with other objects of the disclosure, along withthe various features of novelty which characterize the disclosure, arepointed out with particularity in the claims annexed to and forming apart of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

By way of example only, preferred embodiments of the present disclosurewill be described herein with reference to the accompanying drawings, inwhich:

FIG. 1 is a perspective view of a device for performing a surgicalprocedure, in accordance with an embodiment of the present disclosure,shown in an insertion and/or a withdrawal condition;

FIG. 2 is a perspective view of the device in accordance with theembodiment of FIG. 1, shown in an anchoring and anastomosis condition;

FIG. 3 is an enlarged perspective view of a distal end of a device inaccordance with the embodiment of FIGS. 1-2, shown in the insertion orwithdrawal condition, within a portion of a urinary system;

FIG. 4 is an enlarged perspective view of the distal end of a device inaccordance with the embodiment of FIGS. 1-3, shown in a bladderanchoring condition, within a portion of a urinary system;

FIG. 5 is an enlarged perspective view of the distal end of a device inaccordance with the embodiment of FIGS. 1-4, shown in a retractingand/or approximating condition, illustrating the approximation of thebladder to the urethra;

FIG. 6 is a partial cross-sectional side elevational view of a portionof the urinary system illustrating the bladder approximated to theurethra and a device in accordance with the embodiment of FIGS. 1-5 inthe approximated condition therewithin;

FIG. 7 is a partial cross-sectional side elevational view of a portionof the urinary system illustrating the bladder approximated to theurethra and a device in accordance with the embodiment of FIGS. 1-6 inan anastomosing condition therewithin;

FIG. 8 is a cross-sectional side elevational view of a portion of theurinary system, taken along the longitudinal axis of a device of FIG. 1,illustrating the bladder approximated to the urethra and a device inaccordance with the embodiment of FIGS. 1-7 in the anastomosis conditiontherewithin;

FIG. 9 is an enlarged perspective view of a portion of the urinarysystem illustrating the withdrawal of a device in accordance with theembodiment of FIGS. 1-8, from the anastomosed bladder and urethra whilethe device is in the withdrawal condition; and

FIG. 10 is a cross-sectional side elevational view of a urinary systemillustrating an alternative embodiment of an expandable anchor and anexpandable cuff for the device shown in FIGS. 1-9.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed surgical device willnow be described in detail with reference to the drawing figures whereinlike reference numerals identify similar or identical elements. In thedrawings and in the description which follows, the term “proximal”, asis traditional will refer to the end of the surgical applier which isclosest to the operator, while the term “distal” will refer to the endof the applier which is furthest from the operator.

Referring to FIGS. 1-9, embodiments of devices for performinganastomotic procedures, in accordance with the principles of the presentdisclosure, are shown generally as reference numeral 100. Althoughdevice 100 offers significant advantages to a radical prostatectomyprocedure, it will be understood that the device is applicable for usein any anastomotic procedure where at least two body vessels are to bejoined, such as joining the end of a conduit to a hollow body organ.

Referring now in specific detail to the drawings in which like referencenumerals identify similar or identical elements throughout the severalviews, and initially to FIGS. 1 and 2, anastomotic device 100 is shownin a first condition (i.e., insertion and/or withdrawal condition). Thedevice is desirably configured for passage through a body lumen.Anastomotic device 100 includes a pair of concentric tubular members,preferably, an inner tubular member 102 and an outer tubular member 104slidably disposed about inner tubular member 102. Inner tubular member102 includes a proximal end 106 and a distal end 108. Preferably, distalend 108 is provided with a conical cap 110 in order to facilitateinsertion of device 100 through the body lumen.

Inner tubular member 102 further includes an expandable anchor 114provided near distal end 108 and proximal of an opening 111 formed neardistal end 108 of inner tubular member 102. Preferably, expandableanchor 114 is configured and adapted to surround inner tubular member102. Expandable anchor 114 has an initial condition, as seen in FIG. 1,in which expandable anchor 114 has a radius which is substantially equalto or less than a radius of inner tubular member 102 and an expandedcondition, as seen in FIG. 2, in which expandable anchor 114 has aradius which is greater than the radius of the expandable anchor 114 inthe initial condition. Accordingly, when expandable anchor 114 is in theinitial condition, axial displacement of inner tubular member 102through the body lumen is possible, and when expandable anchor 114 is inthe expanded condition, axial movement of inner tubular member 102through the body lumen is either restricted or prevented.

In the embodiment shown, expandable anchor 114 of inner tubular member102 is a balloon-type anchor. Expandable anchor 114 includes a medicalgrade material and is desirably made of an expandable and/or stretchablematerial. The material of expandable anchor 114 has suitable structuralintegrity and reinforcement for the movement, positioning and/orrepositioning of at least a portion of a hollow body organ afterexpandable anchor 114 has been inflated to the expanded condition. It iscontemplated that the expandable anchor 114 may be reinforced usingextra layers of material strategically positioned. The reinforcingmaterial is desirably expandable and/or stretchable and may take theform of reinforcing strips attached at certain intervals along thesurface of expandable anchor 114 to create a preferred structural shape.The balloon may also comprise an inextensible material and may be formedin a desired shape. The balloon may be wrapped or otherwise secured toinner member 102.

In a preferred embodiment, as seen in FIG. 8, inner tubular member 102is provided with an inflation/deflation lumen 124 extending along thewall of central lumen 112 and is in fluid communication at a distal endthereof with expandable anchor 114 and at a proximal end thereof with asource of fluid 60 for inflation and/or deflation of expandable anchor114. The fluid may include any liquid or gas that is safe for surgicalapplications. For example, air, carbon dioxide, or saline may be used.

Optionally, inner tubular member 102 includes at least one opening 111formed near distal end 108 which opening 111 provides access to acentral lumen 112 (see FIG. 8). Central lumen 112 of inner tubularmember 102 defines a central longitudinal axis “X”. If needed, opening111 and central lumen 112 function much like a Foley-type catheter andpermit fluid to be drained from or infused into the target operativesite and/or define an access channel through which instruments can bepassed, such as optical instruments, in order to aid in the viewing ofsurrounding tissue. Such access channels may also receive instrumentsother than optical instruments.

Returning to FIGS. 1 and 2, outer tubular member 104 includes a proximalend 128 and a distal end 130 defining a lumen 132 extendingtherethrough, in which inner tubular member 102 is slidably disposed.Outer tubular member 104 includes a distal expandable cuff or anchor 140provided near distal end 130 thereof and a proximal expandable cuff oranchor 150 provided at a location proximal of distal expandable cuff140. Each expandable cuff 140, 150 has an initial condition, as seen inFIG. 1, in which expandable cuff 140 or 150 has a radius which issubstantially equal to a radius of outer tubular member 104 and anexpanded condition, as seen in FIG. 2, in which expandable cuff 140 or150 has a radius which is greater than the radius of outer tubularmember 104.

In a preferred embodiment, as seen in FIG. 8, outer tubular member 104is provided with a first inflation/deflation lumen 142 extending alongthe length thereof and which is in fluid communication at a distal endthereof with distal expandable cuff 140 and at a proximal end thereofwith fluid source 60. Outer tubular member 104 is further provided witha second inflation/deflation lumen 152 extending along the lengththereof and which is in fluid communication at a distal end thereof withproximal expandable cuff 150 and at a proximal end thereof with fluidsource 60.

The expandable cuffs 140 and 150 desirably include balloon-typeexpandable cuffs. The balloon-type cuffs are made from material withsuitable structural integrity and reinforcement for the movement,positioning and/or repositioning of at least a portion of a body vesselafter expandable cuff 140 and/or 150 has been inflated to the expandedcondition. The cuffs are made from medical grade material and maycomprise expandable and/or stretchable material. Preferably, the outersurface of each expandable cuff 140 and 150 is configured to providesufficient frictional contact with the inner surface of the body vesselwhen expandable cuff 140 and/or 150 is inflated.

Turning back to FIGS. 1 and 2, device 100 further includes a sleeve 160slidably disposed about outer tubular member 104. Sleeve 160 includes adistal end 162, a proximal end 164 and defines a lumen 166 therethrough.Sleeve 160 preferably has a length sufficient to extend at leastpartially over both expandable anchor 114 of inner tubular member 102and distal expandable cuff 140 of outer tubular member 104 whenexpandable anchor 114 and distal expandable cuff 140 are in theirclosest proximity to one another, such as, for example, when device 100is in the approximated condition, as seen in FIG. 6.

Sleeve 160 is preferably made from a braid, mesh or any other deformablematerial suitable for radial expansion between a first condition havinga first diameter and a second condition having a second diameter largerthan the first diameter. More preferably, sleeve 160 is formed as a meshof individual non-elastic filaments. The filaments may be arranged sothat radial expansion of sleeve 160 results in axial shortening ofsleeve 160. Such an axial shortening of sleeve 160 may be used to helpmaintain in an approximated condition, and/or further helps toapproximate, the body vessels. Sleeve 160 may be of conventionalconstruction, including round filaments, flat or ribbon filaments,square filaments, or the like. Non-round filaments may advantageouslyreduce the axial force required to provide radial expansion of sleeve160.

Alternatively, it is envisioned that sleeve 160 can be a solid flexible,elastic or other deformable material, wherein an outer surface of sleeve160 includes ridges, barbs, knurling or other high friction elements inorder to assist in the engaging and retaining of the body vessels inapposition with one another.

As seen in FIG. 8, device 100 preferably further includes at least oneannular seal (e.g. an O-ring) 170 disposed between inner tubular member102 and outer tubular member 104. Accordingly, it is envisioned thatannular seal 170 prevents or reduces the possibility of fluids frompassing between inner tubular member 102 and outer tubular member 104.

Preferably, device 100 further includes a locking mechanism (not shown)for securing the position of inner tubular member 102 relative to outertubular member 104 and to prevent their relative axial movement withrespect to one another.

A preferred method of use and operation of anastomosis device 100, in aradical prostatectomy procedure, will now be described in greater detailwith reference to FIGS. 1-9 and in particular with reference to FIGS.3-9. With the prostrate removed, bladder neck “N” of bladder “B” isfirst reconstructed by everting the inner mucosal lining of bladder “B”and suturing the inner mucosal lining down to the outer wall of bladder“B” using known surgical techniques. Likewise, urethral stump “S” ofurethra “U” is reconstructed by everting the inner mucosal lining ofurethral stump “S” and suturing the inner mucosal lining down to theouter wall of urethra “U”, using known surgical techniques. The bladderopening is desirably everted first so that the mucosal linings willcontact.

Preferably, with bladder neck “N” reconstructed, bladder neck “N” issized to properly accommodate and retain distal end 108 of inner tubularmember 102 within bladder “B” using a standard tennis racket typeclosure (i.e., the opening of the bladder neck constituting the head ofthe tennis racket and a radial incision extending from the bladder neckconstituting the handle portion of the tennis racket). Most preferably,bladder neck “N” is sized to match the urethra diameter.

As seen in FIG. 3, with bladder neck “N” reconstructed, device 100,including inner tubular member 102, outer tubular member 104 and sleeve160, is passed trans-urethrally through urethra “U” until distal end 108of inner catheter 102 extends out of urethral stump “S” and into bladder“B” through bladder neck “N” as indicated by arrow “A”. In particular,distal end 108 of inner tubular member 102 is preferably positioned suchthat expandable anchor 114 of inner tubular member 102 is positionedentirely within bladder “B”. The device desirably includes a securementdevice, such as a sleeve 160. The sleeve 160 is preferably positionedalong the length of inner tubular member 102 such that distal end 162 ofsleeve 160 is disposed within bladder “B” and at least partially overand surrounding expandable anchor 114 of inner tubular member 102, andproximal end 164 of sleeve 160 extends proximally from bladder neck “N”.

With expandable anchor 114 of inner tubular member 102 positioned atleast substantially within bladder “B”, as seen in FIG. 4, a fluid(e.g., air, carbon dioxide, saline or the like) is introduced throughlumen 124 (FIG. 8) and into expandable anchor 114 in order to expand andinflate expandable anchor 114 within bladder “B”. A syringe or similarmeans may be used to introduce the fluid. Inflation and expansion ofexpandable anchor 114 will inhibit withdrawal or prevent withdrawal ofinner tubular member 102 from bladder “B”, as well as causes distal end162 of sleeve 160 to radially expand within bladder “B”.

As seen in FIG. 5, outer tubular member 104 is desirably positionedwithin urethra “U” such that another anchoring device is positioned inclose proximity with urethral stump “S”. For example, in the embodimentshown, distal expandable cuff 140 is positioned in close proximity withurethral stump “S”. With distal expandable cuff 140 positioned nearurethral stump “S”, a fluid (e.g., air, carbon dioxide, saline or thelike) is introduced through inflation/deflation lumen 152 (FIG. 8) intoproximal expandable cuff 150 to thereby expand and inflate proximalexpandable cuff 150. Inflation of proximal expandable cuff 150 resultsin the radial enlargement of proximal expandable cuff 150 and in turnthe pressing of proximal expandable cuff 150 against the inner surfaceof urethra “U” (see FIGS. 5-8), thus preventing axial displacement ofouter tubular member 104 relative to urethra “U”.

With both expandable anchor 114 and proximal expandable cuff 150 in anexpanded condition, as seen in FIG. 5, inner tubular member 102 iswithdrawn through outer tubular member 104. As inner tubular member 102is withdrawn through outer tubular member 104, in direction “D”, bladder“B” is also moved in direction “D” and approximated toward urethralstump “S”. It is contemplated that once bladder “B” has beenapproximated toward urethral stump “S”, inner tubular member 102 can belocked in position relative to outer tubular member 104 therebymaintaining bladder “B” in approximation with urethra “U”.

The securement device is desirably deployed so as to maintain thebladder and urethra in the approximated position. In the embodimentshown, withdrawal of inner tubular member 102 through outer tubularmember 104 also results in proximal end 164 of sleeve 160 sliding overand being disposed at least partially over distal expandable cuff 140. Afluid (e.g., air, carbon dioxide, saline or the like) is introducedthrough inflation/deflation lumen 142 (FIG. 8) into distal expandablecuff 140 to thereby expand and inflate distal expandable cuff 140 (seeFIG. 6). As seen in FIG. 7, inflation and expansion of distal expandablecuff 140 results in the radial expansion of distal expandable cuff 140and in turn results in the pressing of distal expandable cuff 140against the inner surface of proximal end 164 of sleeve 160 which inturn presses against the inner surface of urethra “U”. As proximal end164 of sleeve 160 is expanded radially, sleeve 160 desirably shortensaxially which causes bladder neck “N” and urethral stump “S” to becomefurther approximated toward one another and to further ensure sufficientcontact exists between bladder neck “N” and urethral stump “S”. Othermeans of securing the position of the body vessels may be used. Forexample, mechanical interengaging parts on the anchors may be used. Theanchors may be left in the body vessels or removed. If left in the bodyvessels, the anchors desirably comprise bio-absorbable materials and aredetachable from the outer and inner tubular members.

In accordance with the present disclosure, biocompatible medical glue oradhesive “M” can be deployed either through device 100 to the outersurface of sleeve 160 or by a separate surgical instrument or syringe200 (FIG. 5). Expandable anchor 114 and distal expandable cuff 140 aremaintained inflated or expanded until medical adhesive “M” has beengiven sufficient time to take an initial set (typically severalminutes). As seen in FIG. 9, expandable anchor 114, distal expandablecuff 140 and proximal expandable cuff 150 are then deflated or retractedand inner tubular member 102 and outer tubular member 104 are withdrawnfrom bladder “B” and urethra “U”, thus completing the anastomosis. Ifnecessary, the connection between the bladder and urethra may be furthersecured using other fastening devices, such as staples, clips, sutures,etc. However, it is contemplated that the sleeve 160 is designed andconfigured for sufficient securement.

Biocompatible adhesive “M” is preferably a non-toxic adhesive having thecapability to adhere to biological tissue, reach stability quickly(e.g., typically within about 30 seconds to about 5 minutes), preferablyable to set in wet conditions, able to bond to both biological tissuesand synthetic materials, and provide sufficient strength. Biocompatibleadhesives made up of proteinaceous materials and cross-linking agentshave these characteristics. Certain examples of biocompatible adhesivescontaining protein and a cross-linking agent are disclosed in U.S. Pat.No. 5,385,606 to Kowanko, the entire disclosure of which is incorporatedherein by reference.

Preferably, sleeve 160 is fabricated from a bio-absorbable material,such as, for example, polyglycolic acid (PGA) and/or polylactic acid(PLA), so that sleeve 160 may be absorbed into the body over time.Sleeve 160 provides an increased surface area for medical adhesive “M”to adhere to and helps to improve the initial strength and patency ofthe anastomosis. Preferably, inner tubular member 102 and outer tubularmember 104 can be coated with a substance which medical adhesive “M”does not have an affinity for thus allowing for inner tubular member 102and outer tubular member 104 not to stick to sleeve 160 when they arebeing withdrawn from bladder “B” and urethra “U”.

According to another aspect of the present disclosure, sleeve 160 can beimpregnated with medical adhesive “M”. In this manner, no modificationsneed to be made to device 100 and no additional instrument is needed toapply medical adhesive “M” to the outer surface of sleeve 160. Accordingto yet another aspect of the present disclosure, sleeve 160 can includemedical adhesive “M” encapsulated within pockets formed therein.Preferably, the pockets are configured to tear or rupture in order todispense medical adhesive “M” between sleeve 160 and bladder “B”,bladder neck “N”, urethral stump “S” and urethra “U”. In use, whenexpandable anchor 114 and distal expandable cuff 140 are inflated andexpanded, expandable anchor 114 and distal expandable cuff 140 compressthe pockets of sleeve 160 against bladder, “B”, bladder neck “N”,urethral stump “S” and urethra “U” causing the pockets to rupture andrelease medical adhesive “M”. Moreover, the pockets are torn open by theradial expansion of sleeve 160 as expandable anchor 114 and distalexpandable cuff 140 are inflated and expanded. The pockets of sleeve 160may include, for example, encapsulating folds which the seal medicaladhesive “M” therein until the expansion of sleeve 160 breaks aseverable seal formed on the encapsulating fold thereby releasingmedical adhesive “M”.

While an annular expandable anchor 114 and annular expandable cuffs 140and 150 have been shown and described, it is within the scope of thepresent disclosure that anchor 114 and cuffs 140 and 150 can have anumber of shapes and configurations, such as, for example, anchor 114and each cuff 140 and 150 can comprise a plurality of balloons radiallydisposed, at least partially, around the outer surface of inner andouter tubular members 102, 104.

Turning now to FIG. 10, an alternative embodiment of a surgical device,substantially similar to device 100 shown in FIGS. 1-9 above, isdisclosed with the exception of expandable anchor 114 and expandablecuff 140. As seen in FIG. 10, when in the expanded condition, expandableanchor 114 includes a proximal portion 114 a shown in FIG. 10 designedor configured to be concave. Accordingly, in a preferred method of use,proximal portion 114 a of anchor 114 is positioned substantially atbladder neck “N” such that when anchor 114 is expanded, proximal portion114 a causes bladder neck “N” to at least partially evert. In addition,as seen in FIG. 10, when in the expanded condition, expandable cuff 140includes a distal portion 140 a, shown in FIG. 10, designed orconfigured to be concave. Accordingly, in a preferred method of use,distal portion 140 a of expandable cuff 140 is positioned substantiallyat urethral stump “S” such that when expandable cuff 140 is expanded,distal portion 140 a causes urethral stump “S” to at least partiallyevert. In this manner, bladder neck “N” and urethral stump “S” can beeverted, to thereby expose the inner mucosal lining to one another,without the need for suturing. The eversion of the body vessels may alsobe assisted by the surgeon. Once bladder “B” and urethra “U” areapproximated toward one another such that the inner mucosal lining ofbladder neck “N” is in contact with the inner mucosal lining of urethralstump “S”, biocompatible adhesive “M” or other fastening means isapplied circumferentially around the anastomosis to help improve theinitial strength and patency of the anastomosis.

It is further envisioned that the proximal end portion of expandableanchor 114 can include a pair of opposed concave surfaces (e.g., adistally oriented concave surface and a proximally oriented concavesurface) defining a peak or apex therebetween (not shown). In addition,it is envisioned that expandable cuff 140 includes a distal portionconfigured and dimensioned to have a diameter substantially equal to thediameter of a proximal end of expandable anchor 114, when bothexpandable anchor 114 and expandable cuff 140 are in the expandedcondition. In a preferred method of use, expandable anchor 114 ispositioned within bladder “B” such that bladder neck “N” is positioneddistally of the apex. In this manner, as expandable anchor 114 isexpanded, the distally oriented concave surface will urge bladder neck“N” to evert. Expandable cuff 140 is then positioned within urethra “U”such that urethral stump “S” preferably extends distally beyondexpandable cuff 140. Accordingly, with expandable cuff 140 in theexpanded condition, when bladder “B” and urethra “U” are approximatedtoward one another, the portion of urethral stump “S” extending distallyof expandable cuff 140 will preferably cam up or ride up the proximallyoriented concave surface of expandable anchor 114. Preferably, urethralstump “S” will ride up and over the everted bladder neck “N” to therebyestablish inner mucosal contact with one another. As described above,once bladder “B” and urethra “U” are approximated toward one anotherbiocompatible adhesive “M” or other fastening means is appliedcircumferentially around the anastomosis to help improve the initialstrength and patency of the anastomosis.

The expandable anchor for engaging a body vessel may comprise anyexpandable structure, including: an onion structure, which comprises atubular body having a plurality of ribs defining a plurality oflongitudinally oriented slots; a balloon or other inflatable structure;a sponge or other device that is expandable upon the introduction ofmoisture; an anchor having a plurality of flexible arms biased toward anexpanded position. The expandable anchor may also comprise thosedisclosed in certain embodiments of the following PCT Applications, allfiled on an even date herewith: Method And Apparatus For AnastomosisIncluding An Anchoring Sleeve, invented by Scott Manzo; Method AndApparatus For Anastomosis Including An Anchor For Engaging A Body VesselAnd Deployable Sutures, invented by Scott Manzo; Method And ApparatusFor Anastomosis Including Annular Joining Member, invented by ScottManzo; Method And Apparatus For Anastomosis Including Annular JoiningMember, invented by Scott Manzo; Method And Apparatus For AnastomosisIncluding An Expandable Member, invented by Russell Heinrich and ScottManzo; Method And Apparatus For Anastomosis Including An AnchoringSleeve, invented by Scott Manzo; the disclosures of which are all herebyincorporated by reference herein, in their entirety.

The joining member for joining body vessels may comprise any joiningmember, including: medical adhesive; a sleeve; surgical staples, clipsand other fixators; sutures; a balloon or other inflatable structure; asponge or other device that is expandable upon the introduction ofmoisture; an anchor having a plurality of flexible arms biased toward anexpanded position; an expandable annular body having body vesselengaging features such as protuberances or barbs. The joining member mayalso comprise the joining members disclosed in certain embodiments ofthe following PCT Applications, all filed on an even date herewith:Method And Apparatus For Anastomosis Including An Anchoring Sleeve,invented by Scott Manzo; Method And Apparatus For Anastomosis IncludingAn Anchor For Engaging A Body Vessel And Deployable Sutures, invented byScott Manzo; Method And Apparatus For Anastomosis Including An AnchorFor Engaging A Body Vessel And Deployable Sutures, invented by ScottManzo; Method And Apparatus For Anastomosis Including An AnchoringSleeve, invented by Scott Manzo; Method And Apparatus For AnastomosisIncluding Annular Joining Member, invented by Scott Manzo; Method AndApparatus For Anastomosis Including Annular Joining Member, invented byScott Manzo; Method And Apparatus For Anastomosis Including AnExpandable Member, invented by Russell Heinrich and Scott Manzo; MethodAnd Apparatus For Anastomosis Including An Anchoring Sleeve, invented byScott Manzo; the disclosures of which are all hereby incorporated byreference herein, in their entirety.

The methods and apparatus disclosed herein may be used for approximatingand/or joining the urethra and bladder, intestinal portions of the body,blood vessels or any other body vessels.

While devices in accordance with the present disclosure have beendescribed as being used in connection with radical prostatectomyprocedures, it is envisioned that devices having similar structures andmodes of operation can be used in various other surgical procedures.Accordingly, it will be understood that various modifications may bemade to the embodiments of the presently disclosed devices and methodsdisclosed herein.

Therefore, the above description should not be construed as limiting,but merely as an exemplification of a preferred embodiment. For example,other expandable anchors may be used. The expandable anchor may comprisea foam or sponge-like material that is expanded upon exposure tomoisture, or deployed upon release from a sleeve compressing the anchor.In addition, the device may include one or more expandable balloon-likeanchors, in combination with other anchors. Those skilled in the artwill envision other modifications within the scope of the presentdisclosure.

What is claimed is:
 1. A method of performing a surgical anastomosis ofa first body vessel and a second body vessel, comprising the steps of:providing a device comprising: an inner member including an expandableanchor for engaging the second body vessel, an outer member having aproximal expandable cuff, a distal expandable cuff and a lumen forreceiving the inner member, and a radially expandable sleeve disposedabout the inner and outer member; passing the device through the firstbody vessel and into the second body vessel; expanding the expandableanchor of the inner member to expand a distal end of the radiallyexpandable sleeve into engagement against the second body vessel;engaging the first body vessel with the proximal expandable cuff of theouter member; then moving the inner member with respect to the outermember so that the second body vessel is approximated with the firstbody vessel; applying a medical adhesive to an outer surface of theradially expandable sleeve; then engaging a juncture between the firstbody vessel and the second body vessel with the radially expandablesleeve by expanding a proximal end of the sleeve by engaging theproximal end of the sleeve with the distal expandable cuff of the outermember, at a location distal of the proximal expandable cuff thereof,thereby securing the approximated position of the first body vessel andthe second body vessel; and maintaining the engagement of the distalexpandable cuff of the outer member with the proximal end of the sleeveand the engagement of the inner member with the distal end of the sleevesubsequent to applying the medical adhesive for a time sufficient topermit the medical adhesive to take an initial set.
 2. The methodaccording to claim 1, further comprising the step of retracting theinner member and the outer member in order to withdraw the device fromthe first and second body vessels after the radially expandable sleevehas secured the approximated position of the first body vessel and thesecond body vessel.
 3. The method according to claim 1, wherein the stepof applying a medical adhesive comprises applying the medical adhesivebetween the sleeve and both of the first body vessel and the second bodyvessel.
 4. The method according to claim 1, wherein the sleeve comprisesa porous material.
 5. The method according to claim 4, wherein themedical adhesive is impregnated in the sleeve.
 6. The method accordingto claim 1, wherein the sleeve is made from a braid of individualnon-elastic filaments so that radial expansion of the sleeve results inaxial shortening of the sleeve.
 7. The method according to claim 1,wherein the expandable anchor is expandable via inflation and furthercomprising inflating the expandable anchor.
 8. The method of claim 1,wherein the proximal expandable cuff of the outer member holds the firstbody vessel while the inner member is moved to approximate the firstbody vessel with the second body vessel.
 9. The method of claim 1,wherein the step of applying a medical adhesive comprises deploying themedical adhesive through a syringe.
 10. The method of claim 2, whereinthe step of moving the inner member with respect to the outer member isperformed until the radially expandable sleeve is substantiallycontained within the first and second body vessels.
 11. A method ofperforming a surgical anastomosis of a first body vessel and a secondbody vessel, comprising the steps of: providing a device comprising: aninner member having an expandable anchor; an outer member having adistal expandable cuff and a proximal expandable cuff and a lumen forreceiving the inner member; a radially expandable sleeve disposed aboutthe inner and outer members, wherein the radially expandable sleeve isimpregnated with a medical adhesive; passing the device through thefirst body vessel and into the second body vessel; then expanding theexpandable anchor of the inner member to (1) effect an expansion of adistal end of the radially expandable sleeve disposed about theexpandable anchor, and (2) press the distal end of the radiallyexpandable sleeve against an inner surface of the second body vessel;then expanding the proximal cuff of the outer member to engage the firstbody vessel at a location proximal of the radially expandable sleeve;then moving the inner member with respect to the outer member so thatthe second body vessel is approximated with the first body vessel; andthen expanding the distal expandable cuff of the outer member to (1)effect an expansion of a proximal end of the radially expandable sleeve,and (2) press the proximal end of the radially expandable sleeve againstan inner surface of the first body vessel such that the medical adhesiveis captured between the proximal and distal ends of the radiallyexpandable sleeve for a time sufficient to permit the medical adhesiveto take an initial set.